Stem Cell Clinical Trials to Tackle Diabetes

Monday, 19 November 2012

NUI Galway has been awarded a major new €6 million European project, designed to address complications associated with diabetes. The research project will examine the ability of stem cells to safely control glucose levels and alleviate the damage caused by six different diabetic complications.

Professor Timothy O’Brien, Director of the Regenerative Medicine Institute (REMEDI) at NUI Galway, who is also a Consultant in Endocrinology at Galway University Hospitals, will co-ordinate the project. Orbsen Therapeutics Limited, an NUI Galway spin-out company, is the lead SME on the project. Clinical trials will take place in Ireland and Denmark using stem cells discovered by Orbsen. In total, nine new research jobs are to be created in Ireland by the project.

An estimated 60 million patients with diabetes mellitus in the EU are using prescription drugs to control blood glucose levels. Poor control of blood glucose levels may lead to a number of diabetic complications, including: nephropathy, retinopathy, cardiomyopathy, neuropathy, impaired bone repair and wound ulceration.

“At the moment, there are very few treatment options available to control the initiation and progression of these complications”, explains Professor O’Brien. “In addition, there are no treatments which will improve glucose levels and simultaneously treat the diabetic complication. These complications therefore continue to be a major challenge for clinicians and patients alike.”

The REDDSTAR project, originally conceived by Dr Steve Elliman, Head of Research & Development at Orbsen Therapeutics, will take place over two phases. The first will examine which diabetic complication responds best to stem cell treatment in various models of diabetes. The second phase will involve a clinical trial at the Steno Diabetes Centre in Denmark, in collaboration with clinicians at the Diabetes Centre in Galway University Hospitals, specifically in the complication which showed the most promising results in the first phase.

Orbsen Therapeutics Limited was formed as a spin out company to advance and commercialise new intellectual property developed by researchers at the SFI-funded REMEDI at NUI Galway. The University has become a leading centre of translational research in adult stem cells involving its National Centre for Biomedical Engineering Science (NCBES) and REMEDI.

Co-ordinated by NUI Galway, the REDDSTAR (Repair of Diabetic Damage by Stromal Cell Administration) project brings together ten expert teams from Ireland, Northern Ireland, Germany, the Netherlands, Denmark, Portugal and the US will comprehensively examine if stem cellscan safely address this challenge.

Converting research funding into job creation

The REDDSTAR EU FP7 funding will be used to create three new positions within REMEDI and a further five new positions at Orbsen. Administration of the REDDSTAR project will be supported by a third SME, Dublin-based EU specialists Pintail Ltd, bringing the total number of new Irish jobs created by this project to nine.

Professor O’Brien states: “The creation of new jobs is a very important impact of government-funded research through Science Foundation Ireland (SFI). The funding of REMEDI by SFI has allowed this EU support to be leveraged resulting in job creation in Ireland.”

Orbsen CEO Brian Molloy adds: “Our participation in REDDSTAR assists us in the development of our core stem cell technology and will make a substantial contribution to our R&D programme. Our mission is to become Europe’s leading Stem Cell Therapy company. Collaborations such as this with REMEDI and NUI Galway help to position Ireland as a European hub for cell therapy development.”

Orbsen recently developed and is patenting a unique method of isolating therapeutic stem cells from human tissue at class-leading levels of purity. The Orbsen cell therapy product is unique in that it has been designed to meet future EU regulations regarding cell-based medicines. The Orbsen therapy will be independently assessed by the REDDSTAR experts in each diabetic complication.

Dr Steve Elliman, states: “This project design has a number of advantages over similar approaches being taken by other researchers. Primarily, this is the first FP7 project to unite EU experts on all six diabetic complications to work together and assess how a therapy might impact all six tissues at the same time. It is expected that this REDDSTAR ‘network’ of researchers will live beyond this project and be used by other drug developers.”

In addition, REDDSTAR has permitted a unique collaboration between Orbsen and the US-based SME, Owl Biomedical Inc. Owl Biomedical is developing the unique “Nanosorter”, a bench-top device that will permit isolation of the Orbsen cell therapy for clinical use in line with forthcoming EU regulations.